MAUDE Adverse Event Report: ST PAUL PORTEX SILICONISED PVC ORAL/NASAL SOFT SEAL CUFF; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/166/065
Medical Device Problem Codes	Fracture (1260); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned for investigation.The returned sample was visually inspected at 12" to 16" under normal conditions of illumination.The inflation line was damaged and under further investigation bite marks were noted along the cut line of the tube.No lot number was provided, so no dhr was able to be done.During the manufacture process though, each device is checked per quality standards.
Event or Problem Description
It was reported that during pre-use check, the customer found a crack in the inflation line.Leakage of air was observed.No patient injury was reported.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problems or issues were identified during this device history record review.One sample was received for evaluation.The sample was received in used conditions without its original packaging.Visual testing was performed.The returned sample was visually inspected at 12" to 16" and normal conditions of illumination.Functional testing was not able to be performed as the inflation line was damaged in half of the tube.The reported issue was not duplicated.This root cause of the reported issue was undetermined.

• Brand Name: PORTEX SILICONISED PVC ORAL/NASAL SOFT SEAL CUFF
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 13446778
• Report Number: 3012307300-2022-02508
• Device Sequence Number: 4304691
• Product Code: BTR
• UDI-Device Identifier: 15019315054075
• UDI-Public: 15019315054075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100/166/065
• Device Catalogue Number: 100/166/065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian